This facility is provided to enable any interested parties to search for Registered Medical Device, Registered CAB, Licensed Establishments under Section 5, 10, 15 of Medical Device Act 2012 (Act 737) respectively and Notified Medical Device under Medical Device (Exemption) Order 2016. Any party who wishes to know whether an establishment who is dealing with medical device has been licensed under Act 737 may search the establishment by inserting the establishment name or license number in the searching field below.


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DEVICE DETAILS

NAME OF DEVICESILICONE FACE MASK
ESTABLISHMENT NAMEAMSMEDIPRO SDN BHD
REGISTRATION NOGMD28181884918A
BRAND NAMECOMFY
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTIONsoft, latex-free, silicone face mask. Designed for attachment to Space Chamber aerosol spacer.
DEVICE INTENDED PURPOSEAttachment to Space Chamber aerosol spacers to deliver asthma or COPD medication for inhalation by patient.
VALIDITY DATE OF REGISTRATION30/11/2023 - 29/11/2028

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1Comfy Silicone Face Mask size 0, NeonatePN-0501-21
2Comfy Silicone Face Mask size 1, InfantPN-0501-22
3Comfy Silicone Face Mask size 2, ToddlerPN-0501-23
4Comfy Silicone Face Mask size 3, ChildPN-0502-21
5Comfy Silicone Face Mask size 4, AdultPN-0502-22
6Comfy Silicone Face Mask size 5, Adult LargePN-0502-23
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